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Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation (Vibrant)

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ClinicalTrials.gov Identifier: NCT03879239
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Vibrant Ltd.

Tracking Information
First Submitted Date  ICMJE February 17, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE March 30, 2019
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
  • CSBM1 & CSBM2 Success Rate [ Time Frame: 8 weeks of treatment ]
    defined as number of subjects with an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment, and CSBM2 success rate, defined as number of subject with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment. The study will be deemed successful if either the CSBM1 or the CSBM2 success rate is statistically significantly higher in the active arm that was continued after the interim analysis, than in the placebo arm
  • Adverse event [ Time Frame: up to 11 weeks ]
    Safety endpoints include all adverse events related and unrelated to the study treatment in all 3 arms
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • CSBM1 & CSBM2 Success Rate [ Time Frame: 8 weeks of treatment ]
    The two primary efficacy endpoints are the CSBM1 success rate, defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment, and CSBM2 success rate, defined as an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment. The study will be deemed successful if either the CSBM1 or the CSBM2 success rate is statistically significantly higher in the active arm that was continued after the interim analysis, than in the placebo arm
  • Adverse event [ Time Frame: up to 11 weeks ]
    Safety endpoints include all adverse events related and unrelated to the study treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
  • straining using VAS scale (0-10) for straining where "0" is no straining and "10" is unbearable straining [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average straining in all 3 arms
  • consistency using the bristol stool scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass) and 7 =watery, no solid pieces, entirely liquid [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average stool consistency, using the Bristol Stool Scale in all 3 arms
  • bloating sing VAS scale (0-10) for bloating where 0=No bloating and 10=Unbearable bloating [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average bloating in all 3 arms
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • straining using VAS scale for straining [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average straining
  • consistency using the bristol stool scale [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average stool consistency, using the Bristol Stool Scale
  • bloating sing VAS scale for bloating [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average bloating
Current Other Pre-specified Outcome Measures
 (submitted: March 17, 2019)
  • CSBM1 [ Time Frame: 8 weeks of treatment ]
    CSBM1 success rate when using the data from the two active arms together
  • CSBM2 [ Time Frame: 8 weeks of treatment ]
    CSBM2 success rate when using the data from the two active arms together
  • SBM [ Time Frame: 8 weeks of treatment ]
    SBM success rate, defined as number of subjects with an increase from baseline period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 6 of the 8 weeks of treatment
  • Rescue [ Time Frame: 8 weeks of treatment ]
    The number of incidence of Rescue Medication use during the treatment period
  • Change in SBM [ Time Frame: 8 weeks of treatment ]
    Change from baseline in weekly number of Spontaneous Bowel Movement (SBM)
  • SBM after firs dose [ Time Frame: 8 weeks of treatment ]
    Number of subject with SBM during the first 24 hours after first dose in all 3 arms
  • Abdominal gas using VAS score (0-10) where 0=No abdominal gas and 10=Unbearable abdominal gas [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average abdominal gas in all 3 arms
  • Abdominal pain using VAS scale (0-10) for Pain , where 0=no pain and 10= Unbearable pain [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average abdominal pain in all 3 arms
  • Abdominal discomfort using VAS scale (0-10) where 0= no discomfort and 10 = Unbearable discomfort [ Time Frame: 8 weeks of treatment ]
    Change from baseline in abdominal discomfort in all 3 arms
  • Time to occurrence [ Time Frame: 8 weeks of treatment ]
    Time to occurrence of spontaneous bowel movement after first capsule activation
  • TSQM - scale is 0-100 . where 0 is not satisfied and 100 is very satisfied [ Time Frame: 8 weeks of treatment ]
    Treatment satisfaction score using the TSQM (Treatment Satisfaction Questionnaire for Medication)
  • PAC-QOL - scale is 0-100 . where 0 is not constipated and 100 is very constipated [ Time Frame: 8 weeks of treatment ]
    Change from baseline in quality of life using the PAC-QOL (Patient Assessment of Constipation Quality of Life) questionnaire
Original Other Pre-specified Outcome Measures
 (submitted: March 14, 2019)
  • CSBM1 [ Time Frame: 8 weeks of treatment ]
    CSBM1 success rate when using the data from the two active arms together
  • CSBM2 [ Time Frame: 8 weeks of treatment ]
    CSBM2 success rate when using the data from the two active arms together
  • SBM [ Time Frame: 8 weeks of treatment ]
    SBM success rate, defined as an increase from baseline period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 6 of the 8 weeks of treatment
  • Rescue [ Time Frame: 8 weeks of treatment ]
    Incidence of Rescue Medication use during the treatment period
  • Change in SBM [ Time Frame: 8 weeks of treatment ]
    Change from baseline in weekly number of Spontaneous Bowel Movement (SBM)
  • SBM after firs dose [ Time Frame: 8 weeks of treatment ]
    Rate of SBM ≤ 24 hours after first dose
  • Abdominal gas [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average abdominal gas
  • Abdominal pain sing VAS scale for Pain [ Time Frame: 8 weeks of treatment ]
    Change from baseline in average abdominal pain
  • Abdominal discomfort sing VAS scale [ Time Frame: 8 weeks of treatment ]
    Change from baseline in abdominal discomfort
  • Time to occurrence [ Time Frame: 8 weeks of treatment ]
    Time to occurrence of spontaneous bowel movement after first capsule activation
  • TSQM [ Time Frame: 8 weeks of treatment ]
    Treatment satisfaction score using the TSQM (Treatment Satisfaction Questionnaire for Medication)
  • PAC-QOL [ Time Frame: 8 weeks of treatment ]
    Change from baseline in quality of life using the PAC-QOL (Patient Assessment of Constipation Quality of Life) questionnaire
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation
Official Title  ICMJE A Prospective, Randomized, Multi-center, Single-Blinded, Placebo-Controlled, 3-Arm Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule, for the Treatment of Chronic Idiopathic Constipation
Brief Summary The study is a prospective, randomized, multicenter, adaptive design, single blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.
Detailed Description

Subjects will come for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks

Three arms will be assessed:

  • Vibrant Capsule mode A administered 5 times per week
  • Vibrant Capsule mode B administered 5 times per week
  • Placebo Capsule administered 5 times per week The difference between the 2 operating modes is in the vibrating sequence during the capsule's operating time.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Idiopathic Constipation
Intervention  ICMJE Device: Vibrating capsule
Vibrating Capsule administered 5 times per week
Study Arms  ICMJE
  • Active Comparator: Vibrant Capsule mode A
    Vibrant Capsule mode A administered 5 times per week
    Intervention: Device: Vibrating capsule
  • Active Comparator: Vibrant Capsule mode B
    Vibrant Capsule mode B administered 5 times per week
    Intervention: Device: Vibrating capsule
  • Placebo Comparator: Placebo Capsule
    Placebo Capsule administered 5 times per week
    Intervention: Device: Vibrating capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2020)
250
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
168
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects aged 22 years and older
  2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives used for at least one month at recommended dose)
  3. Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week
  4. Normal colonoscopy performed within 5 years prior to study participation, unless the subjects are <50 years old and without alarm signs and/or symptoms
  5. Subject signed the Informed Consent Form (ICF)
  6. Female subjects must have a negative blood pregnancy test during screening, confirmed by a negative urine pregnancy test during baseline and must not be lactating prior to receiving study medication. For females of child-bearing potential, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. All other female subjects must have the reason for their inability to bear children documented in the medical record [i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)]; in these circumstances, a pregnancy test will not be necessary

Exclusion Criteria:

History of complicated/obstructive diverticular disease 2. History of intestinal or colonic obstruction, or suspected intestinal obstruction.

3. History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission) 4. History of gastroparesis 5. Use of any of the following medications:

  • Medications that may affect intestinal motility, prokinetics, anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium hydroxide
  • With the exception of antidepressants, thyroid or hormonal replacement therapy, when the subject has been on a stable dose for at least 3 months prior to enrollment.

    6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease 7. Presence of cardiac pacemaker or gastric electrical stimulator. 8. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.

    9. Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically significant rectocele, history of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit 10. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia 11. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study 12. Subjects with pelvic floor dysfunction/defecatory disorder, based on subject history 13. Participation in another clinical study within one month prior to screening.

    14. Women who are pregnant or lactating 15. Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules 16. Inability to use an electronic daily Diary (on a computer, phone application, tablet or other electronic device) to report bowel movements, symptoms and medication usage 17. Subject participated in a previous Vibrant study 18. Subjects planning to undergo MRI during the study 19. Any known allergy to soybean or beeswax or Calcium Carbonate 20. Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03879239
Other Study ID Numbers  ICMJE 270CLD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vibrant Ltd.
Study Sponsor  ICMJE Vibrant Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vibrant Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP